U.S. patent number 8,812,101 [Application Number 13/038,088] was granted by the patent office on 2014-08-19 for method and apparatus to monitor patients and treat with intraosseous fluids.
This patent grant is currently assigned to Vidacare Corporation. The grantee listed for this patent is David S. Bolleter, Larry J. Miller, Robert W. Titkemeyer. Invention is credited to David S. Bolleter, Larry J. Miller, Robert W. Titkemeyer.
United States Patent |
8,812,101 |
Miller , et al. |
August 19, 2014 |
Method and apparatus to monitor patients and treat with
intraosseous fluids
Abstract
Automatic external defibrillator apparatus may be provided for
use in cooperation with an intraosseous apparatus. Apparatus and
methods may also be provided to execute protocols calling for
external defibrillation and drug delivery. The disclosure provides
a medical apparatus including two electrodes, a processor, a
display, a driver, a drug delivery slot, a drug delivery port, and
a voltage source. The two electrodes may include an attachment
operable to releasably connect the two electrodes to the patient.
The processor may be operable to collect and analyze a rhythm
associated with the patient's heart from the two electrodes. The
display may be operable to communicate instructions to a user. The
driver may be operable to insert an intraosseous device into a bone
and associated bone marrow of the patient. The drug delivery slot
may be operable to receive a drug. The drug delivery port may be
operable to communicate the drug from the drug delivery slot to the
patient via the intraosseous device. The voltage source may be
operable to deliver an electric shock to the patient via the two
electrodes.
Inventors: |
Miller; Larry J. (Spring
Branch, TX), Bolleter; David S. (San Antonio, TX),
Titkemeyer; Robert W. (San Antonio, TX) |
Applicant: |
Name |
City |
State |
Country |
Type |
Miller; Larry J.
Bolleter; David S.
Titkemeyer; Robert W. |
Spring Branch
San Antonio
San Antonio |
TX
TX
TX |
US
US
US |
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|
Assignee: |
Vidacare Corporation (Shavano
Park, TX)
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Family
ID: |
40028249 |
Appl.
No.: |
13/038,088 |
Filed: |
March 1, 2011 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20110160781 A1 |
Jun 30, 2011 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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12120992 |
May 15, 2008 |
7899528 |
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60938501 |
May 17, 2007 |
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Current U.S.
Class: |
607/3; 607/5 |
Current CPC
Class: |
A61B
17/3472 (20130101); A61M 39/02 (20130101); A61N
1/3904 (20170801); A61M 39/10 (20130101) |
Current International
Class: |
A61N
1/39 (20060101) |
Field of
Search: |
;600/508,509
;607/2,3,5 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2457105 |
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Dec 1980 |
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FR |
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2516386 |
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May 1983 |
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FR |
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Other References
Extended European Search Report issued in Application No.
08769475.8, dated Sep. 29, 2010. cited by applicant .
International Preliminary Report on Patentability issued in
PCT/US08/63688, dated Nov. 26, 2009. cited by applicant .
International Search Report and Written Opinion issued in
PCT/US08/63688, dated Dec. 1, 2008. cited by applicant.
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Primary Examiner: Gedeon; Brian T
Attorney, Agent or Firm: Fulbright & Jaworski LLP
Parent Case Text
RELATED APPLICATION
This application is a continuation of, and claims priority to, U.S.
patent application Ser. No. 12/120,992, filed May 15, 2008, now
U.S. Pat. No. 7,899,528, which claims the benefit of provisional
patent application entitled "SMART PARAMEDIC," Provisional
Application Ser. No. 60/938,501 filed May 17, 2007. The entire
content of both applications are incorporated by reference.
Claims
What is claimed is:
1. Medical apparatus for treating a patient comprising: two
electrodes, the two electrodes including an attachment operable to
releasably connect the two electrodes to the patient; a processor
operable to collect and analyze a rhythm associated with the
patient's heart from the two electrodes; a display operable to
communicate instructions to a user; a driver operable to rotatingly
insert an intraosseous device into a bone and associated bone
marrow of the patient; a drug delivery slot having at least one
dose of a drug disposed therein; a housing configured to house the
processor and the drug delivery slot; a drug delivery port operable
to communicate the drug from the drug delivery slot to the patient
via the intraosseous device; a voltage source operable to deliver
an electric shock to the patient via the two electrodes; and a
conduit configured to be coupled between the drug delivery port and
the intraosseous device such that the at least one dose of a drug
can be delivered from the housing to a patient via the conduit and
the intraosseous device when the intraosseous device is disposed in
the bone and associated bone marrow of the patient.
2. The medical apparatus of claim 1 further comprising: the
processor operable to analyze the rhythm based on the Advanced
Cardiac Life Support protocol; and the drug delivery port operable
to communicate the drug as prescribed based on the Advanced Cardiac
Life Support protocol.
3. The medical apparatus of claim 1 further comprising a
rechargeable power supply operable to energize the processor, the
display, and the voltage source.
4. The medical apparatus of claim 1 wherein the driver comprises a
battery power supply.
5. The medical apparatus of claim 1 comprising the processor
operable to activate the voltage source.
6. The medical apparatus of claim 1 wherein the housing is further
configured to house the display, the drug delivery port, and the
voltage source.
7. The medical apparatus of claim 6 wherein the housing further
comprises a cradle configured to releasably hold the driver.
8. The medical apparatus of claim 6 wherein the housing further
comprises one or more storage slots configured to releasably hold a
drug container.
9. The medical apparatus of claim 6 further comprising: the driver
including a rechargeable power supply; and the housing including a
charger operable to supply power to the rechargeable power
supply.
10. The medical apparatus of claim 1 further comprising the drug
delivery slot operable to receive a drug cartridge comprising at
least two single unit dose chambers.
11. The medical apparatus of claim 10 further comprising the drug
delivery slot operable to receive a drug cartridge comprising at
least two single unit dose chambers surrounding a central axis.
12. A medical apparatus for treatment of a patient, the apparatus
comprising: a driver operable to rotatingly insert an intraosseous
device into a bone and associated bone marrow of the patient, the
driver configured to be removed from the intraosseous device after
insertion while the intraosseous device remains in the bone; a
processor operable to collect and analyze a rhythm associated with
the patient's heart; a display operable to communicate one or more
instructions to a user in relation to treatment of the patient; a
voltage source operable to deliver a defibrillating shock to the
patient; and one or more instructions with directions to administer
one or more drugs to the patient via the intraosseous device.
13. The apparatus of claim 12 further comprising two electrodes
operable to communicate the rhythm to the processor.
14. The apparatus of claim 12 further comprising the processor
operable to activate the voltage source.
15. The apparatus of claim 12 wherein the one or more instructions
include elements of Advanced Cardiac Life Support protocol.
16. A method for treating a patient comprising: disposing two
electrodes on the chest of the patient; activating an apparatus
operable to collect and analyze a rhythm associated with the
patient's heart; receiving one or more instructions from the
apparatus; rotating with a driver having a rotatable drive shaft an
intraosseous device into the patient's vascular system in response
to the one or more instructions; removing the driver from the
intraosseous device while the intraosseous device is in
communication with the patient's vascular system; coupling a
conduit to and between the apparatus and the intraosseous device;
administering a drug from the apparatus to the patient via the
conduit and intraosseous device in response to the one or more
instructions; and administering a defibrillating shock to the
patient in response to the one or more instructions.
17. The method of claim 16 wherein the apparatus provides the one
or more instructions based on Advanced Cardiac Life Support
protocol.
18. The method of claim 16 wherein the apparatus comprises a
voltage source operable to administer the defibrillating shock via
the two electrodes.
19. The method of claim 16 wherein the method further comprises
connecting the intraosseous device to a drug delivery port
associated with the apparatus.
20. The method of claim 16 wherein the method further comprises
administering a defibrillating shock to the patient after
administering a drug to the patient.
Description
TECHNICAL FIELD
The present disclosure is related to apparatus and methods which
may be used to communicate fluids with a patient's vascular system
via an intraosseous device in cooperation with an automatic
external defibrillator.
BACKGROUND OF THE DISCLOSURE
Automatic external defibrillators (AEDs) are increasingly common
due to concerted campaigns to equip locations with large numbers of
people, such as airports, schools, churches, office building,
and/or other gathering locations. In addition, trained first
responders are often equipped with AED kits. It is asserted that
treatment with an AED significantly increases a patient's chances
of survival in the event of cardiac arrhythmia.
According to the Federal Food and Drug Administration, an AED
typically comprises adhesive electrode pads for connection with a
patient, a microprocessor for collecting and analyzing the rhythms
associated with a patient's heart, and a source of voltage operable
to deliver a shock through the electrodes in an attempt to correct
an arrhythmia. Some AED kits are more properly called
semi-automatic, as they require users to press a button or other
actuator in response to instructions by the AED itself.
In most cases, an AED includes basic instructions for use in the
event a first aid provider is unfamiliar with the equipment. Such
instructions may include pictures or text indicating proper
attachment of the electrodes and/or operation of the electronics in
the kit. Some AEDs, once activated, operate independently by
delivering any appropriate shock without further action by the
user.
Those patient conditions treated with external defibrillation are
often better treated with a combination of defibrillation and drug
administration. For instance, Advanced Cardiac Life Support (ACLS)
protocol promulgated in the United States by the American Heart
Association (AHA) provides a treatment protocol for cardiac
conditions. The ACLS protocol may include external defibrillation,
administration of drugs, and/or insertion of airway devices.
ACLS protocol may include delivery of any drug or medication,
including, but not limited to, calcium, atropine, adenosine,
amiodanone, epinephrine, bicarb, versed, and/or lidocaine. Delivery
of drugs during the course of ACLS protocol may include repeated
injections and/or installing a IV connection.
SUMMARY OF THE DISCLOSURE
In accordance with teachings of the present disclosure, apparatus
and methods may be provided to facilitate access to a patient's
vascular system and to communicate fluids with the vascular system.
These teachings may provide increased effectiveness in treatment of
a patient in accord with an Automatic External Defibrillator.
Apparatus and methods incorporating teachings of the present
disclosure may be used to treat various patient conditions
including, but not limited to, cardiac arrest, ventricular
fibrillation, pulseless ventricular tachycardia, bradycardia and/or
any other sort of cardiac arrhythmia. Installation of an IO device
may offer improved access, increased fluid flow rates and numerous
other benefits over IV fluid delivery or repeated injections.
One aspect of the present disclosure may include providing
apparatus and methods for treating a patient including operating an
automatic external defibrillator in cooperation with insertion of
an intraosseous device disposed in a bone and associated bone
marrow. Structures, apparatus and techniques incorporating
teachings of the present disclosure may be used with a wide variety
of intraosseous devices.
Teachings of the present disclosure may be useful to establish
vascular access during treatment at a wide variety of acute and
chronic conditions at locations and facilities including, but not
limited to, accident sites, emergency rooms, battlefields,
emergency medical services (EMS) facilities, oncology treatment
centers, and chronic disease treatment facilities. Various
teachings of the present disclosure may be used during treatment of
animals in a veterinary practice.
BRIEF DESCRIPTION OF THE DRAWINGS
A more complete and thorough understanding of the present
embodiments and advantages thereof may be acquired by referring to
the following description taken in conjunction with the
accompanying drawings, in which like reference numbers indicate
like features, and wherein:
FIG. 1 is a schematic drawing showing an isometric view of a
powered driver which may be used to place an intraosseous device at
a selected insertion site;
FIG. 2 is a schematic drawing showing a side view of a manual
driver which may be used to place an intraosseous device at a
selected insertion site;
FIG. 3 is a schematic drawing in section and in elevation with
portions broken away showing an exploded view of one example of an
intraosseous device;
FIG. 4 is a schematic drawing showing an isometric view of the
intraosseous device of FIG. 3 disposed in a container;
FIG. 5A is a drawing showing an isometric view with portions broken
away of a supporting structure and attachment mechanism installed
at an insertion site according to one embodiment of the current
disclosure; and
FIG. 5B is a schematic drawing in section taken along line 5B-5B of
FIG. 5A showing an intraosseous device inserted into a bone and
associated bone marrow along with a supporting structure and
attachment mechanism incorporating teachings of the present
disclosure;
FIG. 6 is a schematic drawing in section showing one example of a
connector assembly which may be used to attach a fluid source,
pressure pump, and tubing with an intraosseous device in accordance
with teachings of the present disclosure;
FIG. 7 is a schematic drawing showing one embodiment of an
automatic external defibrillator in accordance with teachings of
the present disclosure;
FIGS. 8A and 8B are drawings showing one embodiment incorporating a
method of operating an automatic external defibrillator in
accordance with teachings of the present disclosure;
FIG. 9A is a schematic drawing showing an embodiment of an
intraosseous device installation kit in accordance with teachings
of the present disclosure;
FIG. 9B is a schematic drawing showing a close-up view of a portion
of an intraosseous device installation kit as depicted in FIG.
9A;
FIG. 10A is a schematic drawing showing an embodiment of an
intraosseous device installation kit in accordance with teachings
of the present disclosure;
FIG. 10B is a schematic drawing showing a close-up view of a
portion of an intraosseous device installation kit as depicted in
FIG. 10A;
FIG. 11 is a schematic drawing showing an embodiment of an
intraosseous device installation kit in accordance with teachings
of the present disclosure;
FIG. 12 is a schematic drawing showing an embodiment of a combined
intraosseous device installation kit and automatic external
defibrillator in accordance with teachings of the present
disclosure;
FIGS. 13A and 13B are schematic drawings showing respective
embodiments of a drug cartridge for use in accordance with
teachings of the present disclosure;
FIG. 14 a schematic drawing showing an embodiment of a combined
intraosseous device installation kit and automatic external
defibrillator in accordance with teachings of the present
disclosure; and
FIG. 15 is a flowchart showing a method of treating a patient in
accordance with teachings of the present disclosure.
DETAILED DESCRIPTION OF THE DISCLOSURE
Preferred embodiments of the disclosure and its advantages are best
understood by reference to FIGS. 1-15 wherein like numbers refer to
same and like parts.
Vascular access is often essential to viability of a patient in
emergency situations, during transportation to a medical facility
and during treatment at the medical facility. Obtaining vascular
access may be a significant problem in five to ten percent of
patients of all ages and weights in pre-hospital and hospital
environments. This equates to approximately six (6) million
patients in the U.S. annually. For example patients suffering from
conditions such as shock, cardiac arrest, drug overdose,
dehydration, diabetic coma, renal failure and altered states of
consciousness may have very few (if any) accessible veins.
In a hospital or similar medical facility, central line access is
often an alternative to IV access. However, central line access
generally takes longer, costs more, may have a higher risk of
complications and requires skilled personnel to properly insert the
central line. In many hospital environments, nurses and physicians
are increasingly turning to intraosseous (IO) access as an
alternative to IV access, rather than central lines. In
pre-hospital environments, paramedics and other emergency medical
service (EMS) providers are often finding that IO access may be
quick, safe and effective when IV placement is challenging.
Intraosseous (IO) access to bone and associated bone marrow has
been used for other procedures including, but not limited to,
obtaining biopsy specimens for analysis and research and also for
bone marrow transplantation and/or stem cell research.
Persons having ordinary skill in the art and practicing the
teachings of this disclosure may be able to combine the benefits of
an automatic external defibrillator (AED) with an IO installation
kit and drug delivery. For example, a combination device may
provide automatic or semi-automatic delivery of defibrillating
shock and IO drugs as identified by the ACLS protocol. In such
cases, the combination device may include all the features of an
AED as discussed in detail above as well as instructions to users
regarding installation of an IO device and automatic or
semi-automatic delivery of drugs as promulgated in the ACLS
protocol.
Teachings of the present disclosure may be satisfactorily used to
communicate fluids with the intraosseous device at a wide variety
of locations. For example, apparatus and methods incorporating
teachings of the present invention may be used to provide
intraosseous access to a patient's vascular system in the sternum,
the proximal humerus (the shoulder area), the proximal tibia (below
the knee), and the distal tibia (above the inside of the ankle).
Teachings of the present disclosure are not, however, limited to IO
devices which may be inserted at the tibia, humerus, or
sternum.
The upper tibia proximate a patient's knee or the humeral head
proximate a patient's shoulder may be used as insertion sites for
an IO device to establish access with the patient's vascular
system. Sternal access may also be used as an insertion site.
Availability of multiple intraosseous sites has proven to be
especially important in applications such as emergency treatment of
battlefield casualties or other mass casualty situation. Teachings
of the present disclosure may be used at a wide variety of
insertion sites.
The distal tibia is located just above the inside of the ankle.
This location may more readily provide vascular access to morbidly
obese patients. The distal tibia is usually a thinner area of the
body. Using the distal tibia as an insertion site may allow
emergency medical service personnel to pump medications and fluids
into the body of obese patients when regular conventional IV access
is difficult. EMS personnel may often not be able to start
conventional IV infusions in obese patients because their size may
obscure many of the veins used for conventional access. Adipose
tissue (fat) around other available IO access sites may be so thick
that EMS personnel cannot reach the bone and associated bone marrow
with available IO needles. In such cases, disposition of an IO
needle in the distal tibia may offer a significant improvement in
vascular access to the overweight population.
The humeral head and sternum further provide insertion sites for an
intraosseous device located above the diaphragm of a patient.
Placing or inserting an intraosseous device above the diaphragm may
be preferred by some emergency room physicians and trauma surgeons
for rapid vascular access.
Intraosseous access may also be used as a "routine" procedure with
chronic conditions which substantially reduce or eliminate the
availability of conventional IV sites. Examples of such chronic
conditions may include, but are not limited to, dialysis patients,
seriously ill patients in intensive care units and epilepsy
patients. Intraosseous devices along with supporting structure
and/or monitoring equipment incorporating teachings of the present
disclosure may be quickly and safely used to provide IO access to a
patient's vascular system in difficult cases such as status
epilepticus to give medical personnel an opportunity to administer
crucial medications and/or fluids. Further examples of such acute
and chronic conditions are listed near the end of this written
description. Insertion sites and associated target areas for IO
placement such as a patient's tibia, humerus, or sternum are often
larger than insertion sites and associated target areas for
placement of an IV device making IO insertion easier than IV
insertion.
The term "driver" may be used in this application to include any
type of powered driver or manual driver satisfactory for installing
an intraosseous (IO) device such as a penetrator assembly or an IO
needle into a selected target site.
For some applications a powered driver or a manual driver may be
directly coupled with an IO device. For other applications various
types of connectors may be used to couple a manual driver or a
powered driver with an IO device. A wide variety of connectors and
associated connector receptacles, fittings and/or other types of
connections with various dimensions and configurations may be
satisfactorily used to releasably engage an IO device with a
powered driver or a manual driver.
The term "intraosseous (IO) device" may be used in this application
to include any hollow needle, hollow drill bit, penetrator
assembly, bone penetrator, catheter, cannula, trocar, inner
penetrator, outer penetrator, IO needle or IO needle set operable
to provide access to an intraosseous space or interior portions of
a bone. A wide variety of trocars, spindles and/or shafts may be
disposed within a cannula during installation at a selected target
area. Such trocars, spindles and shafts may also be characterized
as inner penetrators. A cannula may be characterized as an outer
penetrator.
The term "fluid" may be used within this patent application to
include any liquid including, but not limited to, blood, water,
saline solutions, IV solutions, plasma or any mixture of liquids,
particulate matter, dissolved medication and/or drugs appropriate
for injection into bone marrow or other target sites. The term
"fluid" may also be used within this patent application to include
body fluids such as, but not limited to, blood, bone marrow and
cells which may be withdrawn from a target site.
Various features of the present disclosure may be described with
respect to powered driver 10 and/or manual driver 10a. Various
features of the present disclosure may also be described with
respect to intraosseous device-hub 60. However, intraosseous fluid
delivery systems incorporating teachings of the present disclosure
may be satisfactorily used with a wide variety of drivers and
intraosseous devices. The present disclosure is not limited to use
with intraosseous device-hub 60 or drivers 10 or 10a.
FIG. 1 shows an embodiment of a powered driver 10 which may be
satisfactorily used to insert an intraosseous device into a
selected target area or penetration site. Powered driver 10 may
include housing 12 with various types of motors and/or gear
assemblies disposed therein (not expressly shown). A rotatable
shaft (not expressly shown) may be disposed within housing 12 and
connected with a gear assembly (not expressly shown). Various types
of fittings, connections, connectors and/or connector receptacles
may be provided at one end of the rotatable shaft extending from
end 14 of housing 12.
For some applications pin type fitting or connector 20 may be
formed on the one end of the rotatable shaft. A matching box type
fitting or connector receptacle may be provided on an intraosseous
device so that connector 20 of powered driver 10 may be releasably
engaged with the intraosseous device. For some applications,
connector 20 may have a pentagonal shaped cross section with
tapered surfaces formed on the exterior thereof.
Handle 16 may include a battery (not expressly shown) or other
power source. Handle 16 may also include trigger assembly 18 for
use in activating powered driver 10. Examples of powered drivers
are shown in pending patent application Ser. No. 10/449,503 filed
May 30, 2003 entitled "Apparatus and Method to Provide Emergency
Access To Bone Marrow," now U.S. Pat. No. 7,670,328; Ser. No.
10/449,476 filed May 30, 2003 entitled "Apparatus and Method to
Access Bone Marrow," now U.S. Pat. No. 7,699,850; and Ser. No.
11/042,912 filed Jan. 25, 2005 entitled "Manual Intraosseous
Device," now U.S. Pat. No. 8,641,715.
FIG. 2 shows one example of a manual driver which may be
satisfactorily used to insert an intraosseous device into a
selected target area. For this embodiment manual driver 10a may be
generally described as having handle 16a with a "pistol grip"
configuration. Handle 16a has an ergonomic design with finger grips
22 and one or more finger rests 24.
Connector 20a may extend from first end 14a of handle 16a.
Connector 20a may have a configuration and dimensions similar to
previously described connector 20. However, manual drivers may be
provided with a wide variety of connectors and/or connector
receptacles. Various details concerning manual drivers are
discussed in more detail in pending U.S. patent application Ser.
No. 11/042,912 filed Jan. 12, 2005, entitled "Manual Intraosseous
Driver," now U.S. Pat. No. 8,641,715.
FIG. 3 is a schematic drawing showing an exploded view of one
example of a penetrator assembly which may be used to provide
access to a patient's vascular system. Penetrator assembly or IO
needle set 40 may include connector 30, hub 60 and cover 80.
Connector 30 may be described as having a generally cylindrical
configuration defined in part by first end 31 and second end
32.
First end 31 may include opening 34 formed with various
configurations and/or dimensions. For some applications opening 34
may be sized to receive portions of a drive shaft. One or more webs
(not expressly shown) may also be formed in first end 31 extending
from opening 34. Open segments or void spaces (not expressly shown)
may be formed between such webs. Opening 34 and associated webs (if
any) may be used to releasably engage connector 30 with either a
manual driver or a powered driver.
The configuration and dimensions of opening 34 may be selected to
be compatible with releasably engaging connector 30 of IO needle
set 40 to connector 20 of powered driver 10 or connector 20a of
manual driver 10a. For some applications metallic disk 35 may be
disposed within opening 34 for use in releasably engaging needle
set 40 to a magnet (not expressly shown) disposed on the end of
connector 20 or 20a.
For some applications exterior portion of connector 30 may include
an enlarged tapered portion adjacent to first end 31. A plurality
of longitudinal ridges 33 may also be formed on the exterior of
connector 30 proximate first end 31. The enlarged tapered portion
and/or longitudinal ridges 33 may allow an operator to grasp
associated IO needle set 40 during attachment with a driver and may
facilitate disengagement of connector 30 from hub 60 after outer
penetrator or cannula 70 has been inserted into a bone and
associated bone marrow.
Second opening 36 may be formed in second end 32 of connector 30.
The configuration and dimensions of opening 36 may be selected to
be compatible with releasably engaging the relevant portion of hub
60. For example threads 37 may be formed on interior portions of
opening 36 extending from second end 32. Threads 37 may be sized to
engage threads 67 formed on an exterior portion of hub 60. In
addition, opening 36 may include male luer slip 38, configured to
correspond to female luer slip 68 in hub 60. It should be noted
that male luer slip 38 and female luer slip 68 do not come into
physical contact when connector 30 and hub 60 are connected.
Threads 37 and 67 may be characterized as forming portions of a
Luer lock connection. However, the present disclosure is not
limited to threads 37 and 67. Various types of releasable
connections including, but not limited to, other types of locking
connections may be formed on adjacent portions of connector 30 and
hub 60.
Trocar or inner penetrator 42 may be securely engaged with
connector 30 extending from second end 32. The dimensions and
configuration of inner penetrator 42 may be selected to allow inner
penetrator 42 to be slidably inserted into longitudinal bore 73 of
outer penetrator or cannula 70. Trocar 42 may include first end or
tip 44. The dimensions and configuration of tip 44 may be selected
to accommodate inserting inner penetrator 42 into bone and
associated bone marrow at a selected target area in a patient.
Hub 60 may include first end or distal end 61 and second end or
proximal end 62. First end 61 may include any features selected to
be compatible with connector 30. For example first end 61 of hub 60
may have a generally cylindrical pin-type configuration compatible
with releasably engaging hub 60 with second end 32 of connector 30.
As another example, hub 60 may include threads 67 formed adjacent
to first end 61 of hub 60. Threads 67 may be compatible to be
releasably engaged with threads 37 formed on interior portions of
opening 36 of connector 30.
For some applications first end 61 of hub 60 may be configured to
accommodate various connectors and/or to allow access for various
methods of fluid delivery (e.g., a luer lock, a syringe, a standard
IV connection and/or a needle). For example, first end 61 of hub 60
may include a check valve (not expressly shown), the check valve
operable to allow fluid access via engaged luer lock connections
and to restrict fluid access in the absence of an engaged luer lock
connector. In another example, first end 61 of hub 60 may include a
gasket (not expressly shown) operable to allow fluid access when
punctured by a needle and to restrict fluid access in the absence
of an engaged needle.
For some applications second end 62 of hub 60 may include flange
63. The dimensions and configuration of second end 62 of hub 60 may
be varied to accommodate various insertion sites for an IO device.
Hub 60 may be formed with a wide variety of flanges or other
configurations compatible with contacting a patient's skin adjacent
a desired insertion site.
Passageway 66 may extend from first end 61 through hub 60 to second
end 62. Portions of passageway 66 extending from second end 62 may
have dimensions selected to be compatible with securely engaging
exterior portions of outer penetrator or cannula 70 with hub 60.
Second end 72 of cannula 70 may be disposed within passageway 66
between first end 61 and second end 62. First end 71 of cannula 70
may extend from second end 62 of hub 60. Portions of passageway 66
extending from first end 61 of hub 60 may have an enlarged inside
diameter to accommodate attachment with various types of fluid
connectors.
Cannula or outer penetrator 70 may have longitudinal bore 73
extending from first end 71 to second end 72. Exterior dimensions
of trocar or inner penetrator 42 are preferably selected to allow
inner penetrator 42 be inserted through outer penetrator 70 with
first end 44 of inner penetrator 42 generally aligned with first
end 71 of outer penetrator 70 after threads 67 have been engaged
with threads 37.
Tip 71 of outer penetrator 70 and/or tip 44 of inner penetrator 42
may be operable to penetrate bone and associated bone marrow. The
configuration of tips 71 and 44 may be selected to penetrate a
bone, bone marrow and other portions of a patient's body with
minimum trauma. For some applications tip 44 of inner penetrator 42
may have a generally trapezoid shape with one or more cutting
surfaces.
For some applications tips 71 and 44 may be ground together as a
single unit during an associated manufacturing process. Providing a
matching fit allows respective tips 71 and 44 to act as a single
drilling unit to minimize damage as portions of IO needle set 40
are inserted into a bone and associated bone marrow.
Inner penetrator 42 may sometimes include a longitudinal groove
(not expressly shown) that runs along one side of inner penetrator
42 to allow bone chips and/or tissue to exit an insertion site as
IO needle set 40 is drilled deeper into an associated bone. Outer
penetrator 70 and/or inner penetrator 42 may be formed from various
materials including, but not limited to, stainless steel, titanium
or any other material having suitable strength and durability to
penetrate bone and associated bone marrow. The combination of hub
60 with cannula 70 may sometimes be referred to as an "intraosseous
needle." The combination of trocar 42 with cannula 70 may sometimes
be referred to as a "penetrator set."
Second end 62 and particularly flange 63 may be used to stabilize
hub 60 after insertion into a selected target area of a patient.
Second end 32 of connector 30 may be releasably engaged from first
end 61 of hub 60 after insertion of outer penetrator 70 into
associated bone marrow. The depth of such insertion may be
dependent upon the distance between tip 71 of cannula 70 and second
end 62 of hub 60. Various types of tubing and/or conduit may then
be engaged with threads 67 formed on the exterior of hub 60
proximate first end or pin end 61.
Annular slot or groove 64 may be formed within second end 62 and
sized to receive one end of protective cover or needle cap 80. Slot
or groove 64 may be used to releasably engage cover 80 with hub 60.
For some applications cover 80 may be described as a generally
hollow tube having rounded end or closed end 82. Cover 80 may be
disposed within annular groove 64 to protect portions of outer
penetrator 70 and inner penetrator 42 prior to attachment with a
manual driver or a powered driver. Cover 80 may include a plurality
of longitudinal ridges 84 formed on the exterior thereof.
Longitudinal ridges 84 may cooperate with each other to allow
installing and removing cover or needle cap 80 without
contaminating portions of an associated penetrator needle or IO
device. Cover 80 may be formed from various types of plastics
and/or metals.
Canister 50 as shown in FIG. 4 may include lid 48. Lid 48 may be
configured to allow lid 48 to be flipped open with one or more
digits of an operator's hand. With lid 48 open, an operator may
releasably engage a driver with an IO device disposed in container.
For example, connector 20 of powered driver 10 may be releasably
engaged with connector receptacle 34 of connector 30. Flexible
connector 46 may be used to retain lid 48 with canister 50 after
lid 48 has been opened.
FIGS. 5A and 5B show an intraosseous device inserted into bone and
associated bone marrow along with an attachment mechanism and a
support structure incorporating teachings of the present
disclosure. Various features of the present disclosure may also be
discussed with respect to bone 148 and associated bone marrow 146
as shown in FIGS. 5A and 5B. Bone 148 and bone marrow 146 may be
representative of a portion of a patient's upper arm or humeral
head, but the teachings of the present disclosure are applicable to
any suitable bone or bone marrow.
FIG. 5A shows an isometric view of one embodiment of an
intraosseous device located in the humeral end of a patient and
stabilized with a support structure. In this embodiment, support
structure 130 may include wings 136 and three tabs 134, tabs 134
including adhesive layers 138. Adhesive layers 138 may be disposed
against a patient's skin 145 in position to provide stability to
hub 60. Wings 136 and tabs 134 may be formed from flexible material
operable to conform with exterior portions of hub 60 and/or the
configuration of an insertion site.
FIG. 5A also shows connector assembly 90 may include any system or
device configured to mate with hub 60 and complete a fluid network
with the interior of hub 60. For instance, connector assembly 90
may include luer lock cap 140, right angle connector 142, and
flexible tubing 100. In some embodiments, right angle connector 142
may comprise any hollow component configured to complete a fluid
network between the interior of hub 60 and an external fluid source
and/or receiver such as flexible tubing 100. For instance, right
angle connector 142 may include rigid tubing, piping and/or other
suitable conduits.
FIG. 5B shows a cross section of the embodiment depicted in FIG.
5A, taken along line 5B-5B. As shown in FIG. 5B, an intraosseous
device may be generally described as intraosseous (IO) needle 70
having a hollow, longitudinal bore 73 extending therethrough. First
end or tip 71 of IO needle 70 may be designed to drill or cut
through bone 148 and penetrate associated bone marrow 146. Tip 71
may be open to allow communication of fluids with bone marrow
146.
FIG. 6 shows connector assembly 90 which may be used to communicate
fluids with an intraosseous device in accordance with teachings of
the present disclosure.
Connector assembly 90 may include any appropriate features or
components selected to be compatible with external features of hub
60 or tubing extending therefrom. In some embodiments, such as that
shown in FIG. 5A, connector assembly 90 may include internal
threads 92 selected to be compatible with threads 67 disposed on
hub 60.
Connector assembly 90 may also include any appropriate features or
components selected to facilitate attachment to any suitable
connections (e.g., extension tubes) for fluid delivery or
monitoring devices. For example, connector assembly 90 may include
external threads 94 selected to be compatible with a luer lock or
other threaded connection.
Connector assembly 90 may include components intended to allow
fluid access to hub 60 when appropriate connectors are present. For
example, connector assembly may include plug 96. Plug 96 may be any
compressible material (e.g., rubber and/or synthetic rubber). In
such embodiments, connector assembly 90 may be configured so that
plug 96 is under at least some compression in order to create a
liquid seal against an inner surface of connector assembly 90. For
example connector assembly 90 may include a Halkey-Roberts luer
activated valve. One having ordinary skill in the art may recognize
additional traditional medical equipment that may be compatible
with the IO devices described herein.
FIG. 7 shows Automatic External Defibrillator 110 which may be used
to treat a patient exhibiting cardiac arrhythmia in accordance with
teachings of the present disclosure. AED 110, as shown in FIG. 7,
may include attachable electrodes 112, controls 114, logic
processor 115, handle 116 and display 118. AED may be automatic or
semi-automatic and may be operable to deliver defibrillating shock
under appropriate conditions.
Electrodes 112 may include any suitable means for providing the
appropriate connection to patient 104. For example, electrodes 112
may include electrode pads and/or other connectors. Electrodes 112
may be operable to measure a patient's heart rhythms, blood
pressure, and/or any other appropriate indicator of patient
health.
Controls 114 may include any device configured to allow user 106 to
operate AED 110. In embodiments such as that shown in FIG. 7,
controls 114 may include depressible buttons. In other embodiments,
controls 114 may include any input device (e.g., switches,
touchpads, and/or dials).
Logic processor 115 may include any device or devices for
processing signals received from electrodes 112 (e.g., converting
analog signals to digital signals, and/or interpreting identifiers
(e.g., serial numbers, device codes and/or other codes) of various
components in AED 110). For example, logic processor 115 may
include a device configured to receive a signal generated by
electrodes 112, analyze the received signal, and/or convert the
signal to a format suitable for communication to user 106. Logic
processor 115 may include any suitable hardware or software (e.g.,
any suitable software, algorithms, or other logic or
instructions).
Handle 116 may include any feature of AED 110 that allows user 106
to grasp or manipulate AED 110. In embodiments such as that shown
in FIG. 7, handle 116 may include an extension of the shell
encasing AED 110 as a whole. In other embodiments, handle 116 may
include a strap, an indention of the shell of AED 110, and/or any
other physical feature configured to allow user 106 to grasp AED
110.
Display 118 may include any component of AED 110 configured to
communicate instructions to user 106. In embodiments such as that
shown in FIG. 7, display 118 may include a screen operable to
display text commands to user 106. For example, display 118 may
include an LCD, a plasma display, a set of LEDs, a segment display,
a cathode ray tube, and/or any other useful means of displaying
information. Display 118 may be operable to instruct user 106
regarding proper installation of electrodes 112, proper treatment
of patient 104, and/or any other information useful in the
treatment of patient 104.
FIGS. 8A and 8B show one method for treating patient 104 in
accordance with teachings of the present disclosure. At step 1,
shown in FIG. 8A, user 106 may determine that patient 104 is the
subject of an unknown medical condition that may include a cardiac
condition. User 106 may further dispose AED 110 proximate to
patient 104. User may further operate latch 108 to open the lid of
AED 110. Latch 108 may include any device operable to provide
access to working portions of AED 110.
At step 2, shown in FIG. 8A, user 106 may read or otherwise follow
directions or instructions 119 provided by AED 110. Instructions
119 may include any elements of a treatment protocol, such as ACLS
protocol, and/or other instructions preparatory to delivering
treatment. For example, in embodiments such as that shown in FIGS.
8A and 8B, instructions 119 may include directives to remove the
portion of patient's 104 clothing over his/her chest. In other
embodiments, instructions 119 may include directives to check
patient 104 for responsiveness, a carotid pulse, or other indicator
of the medical condition of patient 104. In some embodiments,
instructions 119 may include directives to make contact with
Emergency Medical Services or other personnel. In embodiments such
as that shown in FIGS. 8A and 8B, instructions 119 may include
directives to prepare and place electrodes 112 in appropriate
locations relative to patient 104.
At Step 3, shown in FIG. 8B, AED 110 may have completed analysis of
cardiac indicators of patient 104. Such indicators may include, but
are not limited to, blood pressure, heart rhythms, and/or any other
measurable quantity or quality related to the cardiac system of
patient 104. AED 110 may collect relevant data through electrodes
112, shown in FIG. 8B as attached to the chest of patient 104 via
leads 113. In other embodiments, AED 110 may collect relevant data
through any combination of sensors operable to deliver a signal to
AED 110.
AED 110, as discussed in relation to FIG. 7, may include a display
or other component intended to communicate instructions 119 to user
106. In embodiments such as that shown in FIG. 8B, AED 110 may
include a sound recording instructing user 106 to activate a shock
to defibrillate patient's 104 heart. User 106 may comply with that
instruction by pressing button 114, or any other actuator or switch
provided by AED 110. AED 110 may also provide additional
directives, such as an instruction to ensure no one is in physical
contact with patient 104.
FIG. 9A illustrates one example of an intraosseous device placement
kit 120 in accordance with teachings of the current disclosure.
FIG. 9B shows a close-up of one feature that might be included in
embodiments such as that shown in FIG. 9A. Kit 120 may include a
case and/or bag configured to house and/or transport implements,
tools, and/or other material that might be useful in placing an IO
device in accordance with teachings of the present disclosure. In
embodiments such as that shown in FIG. 9A, kit 120 may include
first side 122, second side 124, handle 121, and zipper 126.
Handle 121 may include any device, feature or characteristic of kit
120 configured to facilitate grasping or manipulation of kit 120 by
user 106. For example, handle 121 may include a depression in the
body of kit 120 configured to fit user's 106 hand or fingers, a
separate piece of material attached to the body of kit 120, or an
extension of some part of the body of kit 120. In examples such as
that shown in FIG. 9A, handle 121 may include a rugged piece of
material (e.g., fabric, plastic, metal, and/or any other suitable
material) attached to second side 124 of kit 120.
Kit 120 may include first side 122 and second side 124 configured
to contain and/or protect the components within kit 120. Kit 120
may also include any combination configured to allow user 106 to
access the components within kit 120. For example, in embodiments
such as that shown in FIG. 9A, kit 120 may include a generally
block-shaped box with first side 122 including some fraction of the
total box and second side 124 including the remaining portion of
the total box. The interior volume of each side may be configured
to house the components within kit 120. At the same time, the
separation of first side 122 from second side 124 may allow user
106 to access the components.
Zipper 126 may include any component or device configured to
releasably join first side 122 with second side 124. Zipper 126 may
include features or designs configured to interact with user's 104
fingers or hands to facilitate the user 104 opening kit 120. In
embodiments such as that shown in FIG. 9A, opening kit 120 may
consist of operating zipper 126 to allow separation of first side
122 from second side 124. In such embodiments, zipper 126 may
include pulls 127, tabs or other components configured to
facilitate the operation of zipper 126. In other embodiments,
opening kit 120 may consist of operating any sort of connector
(e.g., a clasp, buckles, straps, velcro-brand hook and loop
fasteners, and/or any other releasable connector).
FIG. 9B shows a close-up of one portion of kit 120. Kit 120 may
include latch 128. Latch 128 may include any device or mechanism
configured to restrict accidental, inadvertent or unauthorized
operation of zipper 126. In embodiments such as that shown in FIG.
9B, zipper 126 may include latch 128. Latch 128 may be configured
to restrict the accidental or inadvertent separation of pulls 127.
In addition, latch 128 may be configured to open or release with
minimal effort by user 104, such as by pulling or squeezing latch
128 (e.g., as is present in conventional devices like some
keyrings, carabineers, and/or any other quick-release
mechanism).
FIG. 10A shows a schematic drawing of kit 120 in the open state,
including interior features. Kit 120 may include IO driver bracket
160, interior partition 170, and/or assorted pockets and features
configured to store or contain items useful in the installation of
an intraosseous device. Persons having ordinary skill in the art
will recognize that the interior of kit 120 may be configured or
constructed from a wide variety of materials and in a wide variety
of shapes and sizes as appropriate for the items intended to be
placed in kit 120. Although the interior of kit 120 is herein
described with respect to the embodiment shown in FIGS. 10A and
10B, the teachings of the present disclosure are not limited to
such embodiments.
Bracket 160 may include any component or device configured to
releasably store powered driver 10 or manual driver 10a and/or any
other device configured to facilitate insertion of an intraosseous
device. Bracket 160 may include extended sides 162, cradle 164,
base 166, and connectors 168. Bracket 160 may be fabricated from
extruded plastic, molded plastic, wood, and/or any other material
suitable for forming the desired shape. In some embodiments,
bracket 160 may include elastic straps, and/or any combination of
straps and fasteners (e.g., Velcro, hooks, buckles, etc.).
Extended sides 162 may include any feature of bracket 160
configured to extend from the main body of bracket 160. In
embodiments such as that shown in FIG. 10A, extended sides 162 may
include basically planar bodies as well as lip 163 and/or other
feature. Lip 163 may include any feature of extended sides 162
configured to snap on to or grip driver 10 and to withstand
incidental and/or inadvertent forces applied to driver 10.
Cradle 164 may include any component or feature of bracket 160
configured to conform or otherwise interact with handle 16 of
driver 10. Cradle 164 may include a shape substantially matching
handle 16 for one specific driver 10 or it may include a general
shape configured to interact with a wide variety of drivers 10.
Base 166 may include any component or feature of bracket 160
configured to provide attachment points between bracket 160 and the
interior of kit 120. In embodiments such as that shown in FIG. 10A,
bracket 160 may be fastened to second side 124. In other
embodiments, bracket 160 may be attached to any other feature or
part of kit 120. In addition, bracket 160 may be formed
monolithically with one or more portions of kit 120 and may not
include base 166 at all.
Connectors 168 may include any device or component configured to
connect base 166 and/or bracket 160 to kit 120. Connectors 168 may
include permanent connectors (e.g., rivets, and/or nails) or may
include releasable and reusable fasteners (e.g., bolts, screws,
and/or studs). In embodiments such as that shown in FIG. 10A,
connectors 168 may include rivets and washers permanently fastening
bracket 160 within kit 120.
Interior partition 170 may include any component or feature of kit
120 operable to segregate interior compartments of kit 120. In
addition, interior partition 170 may be configured to store devices
or components of an IO installation device. In embodiments such as
that shown in FIG. 10A, interior partition 170 may include divider
172, flexible connector 174, pockets 176 and loops 178.
Divider 172 may include any feature or component of interior
partition 170 configured to separate one interior portion of kit
120 from another. For example, divider 172 may include a sheet of
sturdy flexible material. In other embodiments, divider 172 may
include a rigid divider, a lid for one or more interior
compartments, or similar structure.
Flexible connector 174 may include any feature or component of
interior partition 170 configured to allow relative motion between
interior partition 170 and kit 120. For example, flexible connector
174 may include a strip of fabric or plastic. In other examples,
flexible connector 174 may include an articulate component (e.g., a
hinge, clevis pin, and/or other joint).
Pockets 176 may include any feature or component of interior
partition 170 configured to house or contain devices or component
configured to facilitate the insertion or use of an IO device in
accordance with teachings of the present disclosure. In embodiments
such as that shown in FIG. 10A, pockets 176 may include portions of
fabric, plastic or another material connected to interior partition
170 and configured to allow insertion and removal of devices,
paper, cards, or other useful items. For example, pockets 176 may
include compartments configured to allow the insertion and removal
of index cards or pre-printed cards with instructions for use or
other useful information.
Loops 178 may include any component or feature of interior
partition 170 configured to releasably hold components of IO
insertion devices or kit 120. For example, loops 178 may include
strips of elastic material configured to stretch for insertion of
components and retract to hold those components securely. In some
embodiments, loops 178 may include fabric or plastic material.
Persons having ordinary skill in the art will recognize that loops
178 and pockets 176 may be made of any size, shape and
configuration appropriate to house any device or component suitable
for kit 120.
FIG. 10B shows a close-up view of bracket 160 along with driver 10.
FIG. 10B depicts one embodiment of powered driver 10 present and
stored within bracket 160. In embodiments such as that depicted in
FIG. 10B, bracket 160 may be configured to conform closely to the
shape and dimensions of powered driver 10 and specifically, to
handle 16. Extended sides 162 may be configured to protrude from
base 166 and enclose a significant portion of handle 16. In
addition, extended sides 162 may include lips 163 configured to
restrict handle 16 from separation from bracket 160. In such
embodiments, lips 163 may be configured to protrude above handle 16
when driver 10 may be present in bracket 160. In other embodiments,
lips 163 may be configured to interface with one or more features
of handle 16 to provide a physical stop. In such embodiments, the
physical resistance to motion may be configured to resist
incidental or inadvertent forces but to yield easily to purposeful
removal of driver 10.
FIG. 11 shows an example of kit 120 in accordance with teachings of
the current disclosure, depicting driver 10 present in bracket 160.
In addition, FIG. 11 depicts components configured to facilitate
providing an electric charge to driver 10 while present in bracket
160. Kit 120 may include charger 180, cord 182, power indicator
184, and charging indicator 186.
Charger 180 may include any device or component configured to
provide an electrical connection between an external source of
electricity and driver 10. For example, charger 180 may include an
AC/DC converter, electric contacts, or any other components useful
in supplying power to driver 10.
Power cord 182 may include any device or component configured to
connect charger 180 to an external source of power. For example,
power cord 182 may include cable, wire, conductors and/or any
peripheral devices useful for creating an electrical connection
such as a two- or three-prong plug.
In embodiments such as that shown in FIG. 11, charger 180 may
include power indicator 184 and charging indicator 186. Such
indicators are well-known in applications for rechargeable
household appliances such as cordless telephones, wireless shavers,
and the like. In such embodiments, power indicator 184 may include
an LED that emits green light when charger 180 is connected to an
active power source. In such embodiments, charging indicator 186
may include an LED that emits red light when driver 10 is
accumulating an electrical charge.
FIG. 12 is a depiction of an embodiment of apparatus 200 combining
AED 110 and IO installation kit 120 in accordance with teachings of
the present disclosure. In such embodiments, apparatus 200 may
include electrodes 112, electrode port 202, display 204, controls
206, processor 208, driver cradle 210, drug delivery slot 220, and
drug delivery port 230. In other embodiments, not all of these
features may be present.
Electrodes 112, as described in more detail with relation to FIG.
7, may include any device configured to releasably connect
apparatus 200 with patient 104 and operable to collect cardiac
information from patient 104.
Electrode port 202 may include any connector configured to connect
electrodes 112 with processor 208 both physically and for the
transfer of data. For example, electrode port 202 may include,
e.g., twist-on wire connectors, terminals, terminal blocks, banana
plugs, crimp-on terminals, lugs, plug and socket connectors, DIN
connector, D-subminiature plugs, registered jack and/or any other
suitable connectors.
Display 204 may include any device or component operable to
communicate data or instructions to user 106. For example, display
204 may include a LCD screen or touchpad such as those used in
laptop computers. In other examples, display 204 may include a
plasma display, a set of LEDs, a segment display, a cathode ray
tube, and/or any other useful means of displaying information.
Display 204 may be operable to instruct user 106 regarding proper
installation of electrodes 112, proper treatment of patient 104,
and/or any other information useful in the treatment of patient
104.
Controls 206 may include any device configured to allow user 106 to
operate apparatus 200. In embodiments such as that shown in FIG.
12, controls 206 may include depressible buttons. In other
embodiments, controls 206 may include any similar input device
(e.g., switches, touchpads, and/or dials). As example functions,
controls 206 may be operable to indicate electrodes 112 have been
attached to patient 104, to query processor 208, to activate a
defibrillating shock, to deliver drugs or medication present in
drug delivery slot 220, or any other function useful in practicing
the teachings of the present disclosure.
Processor 208 may include any device or devices for processing
signals received from electrodes 112 (e.g., converting analog
signals to digital signals, and/or interpreting identifiers (e.g.,
serial numbers, device codes and/or other codes) of various
components in apparatus 200). For example, processor 208 may
include a device configured to receive a signal generated by
electrodes 112, analyze the received signal, and/or convert the
signal to a format suitable for communication to user 106.
Processor 208 may include any suitable hardware or software (e.g.,
any suitable software, algorithms, or other logic or
instructions).
Driver cradle 210 may include any feature or component of apparatus
200 configured to releasably contain driver 10 or manual driver
10a. In some embodiments, driver cradle 210 may include any
features of bracket 160 discussed in relation to FIG. 10A. In other
embodiments, such as that shown in FIG. 12, driver cradle 210 may
include sidewalls 212 and bottom 214.
Sidewalls 212 may include any feature or component of apparatus 200
configured to releasably hold driver 10 or manual driver 10a until
user 106 prepares to install an IO device. Sidewalls 212 may be
configured to hold driver 10 with IO needle set 40 connected to
driver 10 or without IO needle set 40 connected to driver 10. In
some embodiments, such as that shown in FIG. 12, sidewalls 212 may
include smooth and flat panels as in commonly available phone
handset cradles.
Likewise, bottom 214 may include any configuration suitable for
releasable storage of driver 10 or manual driver 10a. For example,
bottom 214 may include a substantially flat, smooth portion of
apparatus 200. As another example, bottom 214 may include
indentions and protrusions configured to interface with features or
components of driver 10 and/or manual driver 10a. In some
embodiments, bottom 214 may include features or components operable
to deliver an electric charge to a battery or power source within
driver 10.
Drug delivery slot 220 may include any feature or component of
apparatus 200 configured to receive an infusion of medication or
drugs preparatory to delivery to patient 104. In some embodiments,
such as that shown in FIG. 12, drug delivery slot may be configured
to accept and dispense drugs stored in cartridges 226. In such
embodiments, drug delivery slot 220 may include top 222 and
sidewalls 224. Drug delivery slot 220 may include any features or
devices configured to delivery drugs and/or medication from
cartridge 226 to drug delivery port 230 and to a patient, e.g.,
through flexible tubing 100 and connector assembly 90 to an IO
device. In some embodiments, drug delivery slot 220 may include
features for accepting a plurality of cartridges 226. For example,
drug delivery slot 220 may include six slots for accepting unit
dose cartridges of drugs used in the practice of ACLS.
Top 222 may include any feature or component of drug delivery slot
220 configured to adapt to cartridge 226. For example, top 222 may
include devices configured hold cartridge 226 by operating in a
similar manner as a battery retainer in a conventional handheld
electronic device. In other embodiments, top 222 may include a
flexible protrusion configured to create a friction fit with
cartridge 226, an extension configured to protrude above cartridge
226 when cartridge 226 is present in drug delivery slot 220, or any
other feature configured to hold cartridge 226 in place until user
106 desires to remove cartridge 226.
Sidewalls 224 may include any feature or component of drug delivery
slot 220 configured to adapt to cartridge 226. For example,
sidewalls 224 may include devices configured hold cartridge 226 by
operating in a similar manner as a battery retainer in a
conventional handheld electronic device. In other embodiments,
sidewalls 224 may include a flexible protrusion configured to
create a friction fit with cartridge 226, an extension configured
to protrude above cartridge 226 when cartridge 226 is present in
drug delivery slot 220, or any other feature configured to hold
cartridge 226 in place until user 106 desires to remove cartridge
226.
Storage slots 232 may include any feature or component of apparatus
200 configured to releasably hold cartridge 226. For example,
storage slot 232 may include a cylindrical socket in the body of
apparatus 200 shaped to provide a snug fit around cartridge 226. In
some embodiments, storage slots 232 may be located in the side,
top, or bottom of apparatus 200. In other embodiments, cartridges
226 may be stored in kit 120 or pockets 174 and loops 176
associated with apparatus 200.
In other embodiments, drug delivery slot may be configured to
receive drugs without interface with cartridge 226. For example,
drug delivery slot 220 may include a rubber gasket suitable for
puncture by a hypodermic needle.
Drug delivery port 230 may include any feature or component of
apparatus 200 configured to provide an interface between drug
delivery slot 220 and flexible tubing 100 and connector assembly 90
(discussed in relation to FIGS. 5 and 6). For example, drug
delivery port 230 may include a luer lock connection. Drug delivery
port 230 may include any other appropriate joint (e.g., a valve, a
threaded fitting, a plug and socket, and/or any component
appropriate to provide a fluid connection between apparatus 200 and
patient 104).
FIGS. 13A and 13B show examples of cartridges which may be used
with medical apparatus incorporating teachings of the present
disclosure. Cartridges 226a and 226b may include any device
configured to store a medication or drug and interface with
apparatus 200. Cartridges 226a and 226b may be configured to fit in
storage slots 232 as well as drug delivery slot 220. Cartridges
226a and 226b may include a canister, a vial, a syringe, and/or any
other pre-filled sterile container appropriate for the storage of
medications and/or drugs. In some embodiments, cartridges 226a and
226b may include a known single unit dose drug cartridge. In some
embodiments, cartridges 226a and 226b may include a marker
identifying the contents of cartridges 226a and 226b (e.g.,
color-coding, text, chemical formulations, and/or any other
information that may be used to indicate the contents of cartridges
226a and 226b to a user).
In other embodiments, such as those shown in FIGS. 13A and 13B,
cartridges 226a and 226b may include multiple chambers 240a and
240b. In such embodiments, each chamber may be configured to hold a
single dose of a medicine, drug, and/or a flushing solution. In
such embodiments, drug delivery slot 220 may include any features
and/or devices configured to select a chamber, provide a fluid
connection between the chamber and drug delivery port 230, deliver
fluid from the chamber to drug delivery port 230 and then to a
patient (e.g., via flexible tubing 100, connector assembly 90 and
an IO device). Those embodiments of cartridges 226a and 226b with
multiple chambers may include a rotating component that alternates
drug chambers with chambers filled with sterile solutions. In such
embodiments, drug delivery slot 220 may inject fluid from the
chambers filled with sterile solution after injecting fluid from a
drug chamber to flush drug delivery port 230, flexible tubing 100,
connector assembly 90, and/or an IO device.
As shown in FIG. 13A, cartridge 226a may have a generally
cylindrical configuration with rigid walls. Chambers 240a may be
disposed around a central axis 242. In such embodiments, each
chamber 240a may be filled with a single dose of a drug,
medication, and/or sterile flushing fluid. In such embodiments,
drug delivery slot 220 may include any necessary components or
features configured to deliver the contents of each chamber 240a
and to rotate cartridge 226a around axis 242 as needed to access
each chamber 240a.
FIG. 13B shows another embodiment of cartridge 226b including
multiple chambers 240b. Cartridge 226b may have a generally
rectangular configuration with relatively rigid walls.
Alternatively, cartridge 226b may be formed from relatively
flexible material to accommodate storage, insertion, and removal
from an associated medical device and/or apparatus.
Cartridge 226 may include one or more chambers 240b disposed along
the length of cartridge 226. In such embodiments, each chamber 240b
may be filled with a single unit dose of drug, medication and/or
sterile flushing solution. In such embodiments, drug delivery slot
220 may include any necessary components or features configured to
deliver the contents of each chamber 240b as needed by apparatus
200.
FIG. 14 depicts one embodiment of apparatus 200 in accordance with
teachings of the present disclosure. In embodiments such as that
shown in FIG. 12, apparatus 200 may include the features previously
discussed in relation to kit 120 and AED 110. Such embodiments may
include driver 10, electrodes 112, interior partition 170, charger
180, electrode port 202, display 204, controls 206, processor 208,
driver cradle 210, drug delivery slot 220, and drug delivery port
230. Such embodiments may provide a single kit operable to perform
the functions previously described in relation to AED 110 and kit
120.
FIG. 15 shows a flowchart depicting a method 300 of treating
patient 104 by user 106 including apparatus 200, a combination AED
and IO drug delivery kit, in accordance with teachings of the
present disclosure. At step 310 patient 104 may be identified,
which may include recognizing physical signs of distress, hearing a
call for help, responding to a call for emergency services, or any
other process capable of identifying patient 104.
At step 320, the lack of responsiveness of patient 104 may be
confirmed. Step 320 may include performing preliminary diagnosis,
asking questions, receiving information from witnesses and/or
bystanders, and/or any other suitable procedure intended to confirm
the condition of patient 104.
At step 330, apparatus 200 may be engaged for the treatment of
patient 104. Engagement of apparatus 200 may include opening
apparatus 200 to expose display 204, controls 206 and/or
instructions. Engagement of apparatus 200 may be retrieved from a
wall-mount, an emergency vehicle, a supply of medical equipment,
and/or any other storage facility or transport equipment suitable
for carrying or storing apparatus 200. Engagement of apparatus 200
may include following any directions or instructions included with
apparatus 200 or provided by display 204.
At step 340, electrodes 112 may be applied to patient 104.
Application of electrodes 112 may include removal of clothing or
other obstacles to the chest of patient 104. Application of
electrodes 112 may include releasably connecting electrodes 112 to
appropriate portions of patient's 104 skin.
At step 350, apparatus 200 may be activated. In some embodiments,
activation of apparatus 200 may include operation of controls 206.
In other embodiments, activation of apparatus 200 may include
apparatus 200 sensing that electrodes 112 are in place and
automatically engaging in analysis of any data gathered. Activation
of apparatus 200 may include switching apparatus 200 on and/or any
other method of activating the power circuitry of apparatus
200.
At step 360, a recommended treatment protocol may be followed. In
some embodiments, recommended treatment protocol may include ACLS
treatment protocol for cardiac arrhythmia. Following a recommended
treatment protocol may include responding to directions or
instructions provided by apparatus 200, communicated on display
204, and/or any other method of instructing user 106.
At step 370, IO needle set 40 may be inserted into the vascular
system of patient 104. Insertion of IO needle set 40 may be a part
of instructions or directions provided by apparatus 200. Insertion
of IO needle set 40 at step 370 may include the use of any of the
IO insertion components discussed in the present disclosure.
Insertion of IO needle set 40 may include connecting apparatus 200
to flexible tubing 100 via drug delivery port 230 or any other
component providing access to the vascular system of patient
104.
At step 380, drugs or medication may be administered to patient
104. Administration of drugs may be as a response to instructions
or directions provided by apparatus 200. Administration of drugs
may include insertion of cartridge 226 into drug delivery slot 220
and/or any other means of communicating drugs from apparatus 200 to
patient 104. Administration of drugs may be accomplished by user
106 activation of control 206 or may include an automatic function
of apparatus 200 upon analysis of data collected via electrodes
112. In some embodiments, apparatus 200 may administer drugs
without user interaction, e.g., automatically delivering drugs from
a multi-chamber drug cartridge 226. In such embodiments, apparatus
200 may administer a first drug from one chamber followed by a
flushing solution from a second chamber of cartridge 226.
At step 390, defibrillating shock may be administered to patient
104. Administration of defibrillating shock may be as a response to
instructions or directions provided by apparatus 200.
Administration of defibrillating shock may be accomplished by user
106 activation of control 206 or may include an automatic function
of apparatus 200 upon analysis of data collected via electrodes
112.
Although the present disclosure and its advantages have been
described in relation to intraosseous devices, it should be clear
to a person having ordinary skill in the art that these teachings
can be applied to support a variety of medical devices in relation
to a patient. For example, embodiments of the present disclosure
might be utilized to provide fluid to any intravenous connection or
device, a central line, an endotracheal tube, a chest tube, a
catheter, dialysis tubing and/or any other device intended to make
a fluid connection to one or more systems of the patient.
Examples of acute and chronic conditions which may be treated using
intraosseous devices and procedures incorporating teachings of the
present disclosure include, but are not limited to, the following:
Anaphylaxis (epinephrine, steroids, antihistamines, fluids, and
life support) Arrhythmia (anti-arrhythmics, electrolyte balance,
life support); Burns (fluid replacement, antibiotics, morphine for
pain control); Cardiac arrest (epinephrine, atropine, amiodarone,
calcium, xylocaine, magnesium); Congestive heart failure (life
support, diuretics, morphine, nitroglycerin); Dehydration
(emergency port for life support, antibiotics, blood,
electrolytes); Diabetic Ketoacidosis (life support, electrolyte
control, fluid replacement); Dialysis (emergency port for life
support, antibiotics, blood, electrolytes); Drug overdose
(naloxone, life support, electrolyte correction); Emphysema (life
support, beta adrenergics, steroids); Hemophiliacs (life support,
blood, fibrin products, analgesics); Osteomyelitis (antibiotics
directly into the site of infection, analgesics); Pediatric
applications (shock, dehydration, nutrition, electrolyte
correction); Seizures (anti-seizure medications, life support,
fluid balance); Shock (life support fluids, pressor agents,
antibiotics, steroids); Sickle cell crisis (fluid, morphine for
pain, blood, antibiotics, exchange transfusion); Trauma (emergency
port for life support fluids, antibiotics, blood,
electrolytes);
Although the present disclosure and its advantages have been
described in detail, it should be understood that various changes,
substitutions and alternations can be made herein without departing
from the spirit and scope of the disclosure as defined by the
following claims.
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